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ICAR SINONASAL TUMORS

TABLE XXIII.A.3 (Continued)

Clinical endpoints

Study

Year LOE Study Design Study groups

Conclusions

Stevens et al. 1244 2005 3

1. OS 2. EFS

1. Group 1: 5-year OS of 59%, 33% 5-year EFS in cohort treated with induction chemotherapy protocol 2. Group 2: 5-year OS of 65%, 62% 5-year EFS in cohort treated withCRT

Prospective cohort

Group 1: IVA, CEV, IVE (induction) RT if less than CR

( n = 27) in PM-RMS, < 3 years of age

Group 2: IVA or IVA + CEV All received RT

( n = 85) in PM-RMS, ≥ 3 years of age Doses of intrathecal chemotherapy for PM-RMS with meningeal involvement, zero doses versus four versus 13 protocol, all received chemotherapy ( n = 222) in PM-RMS treatment based on response ( n = 51) in PM-RMS stage 3 Induction IVA then IVA if PR or DP if less than PR High-risk PM-RMS, > 5 years of age: same as low-risk except addition of RT after induction High-risk PM-RMS, < 5 years of age: Induction IVA then IVA if PR or DP if less than PR If CR, then continued All received RT Low-risk PM-RMS: chemotherapy. If less than CR, then RT( n = 41) b protocol, all received chemotherapy ( n = 121) in PM-RMS IRSG 3 Risk stratified VAIA, adjuvant ( n = 360) Risk stratified

Raney et al. 1224

2002 3

Prospective cohort

OS

No OS benefit with administration of intrathecal chemotherapy a

Crist et al. 1226

FFS

No change in FFS from previous IRS studies for PM-RMS

2001 3

Prospective cohort

Koscielniak et al. 1247

1999 3

Prospective cohort

EFS

1. 5-year EFS 59% 2. 95% of PM-RMSs were Stage 3

Flamant

1998 3

Prospective cohort

1. OS 2. EFS

1. 5-year OS of 58% for entire PM-RMS cohort 2. There were no low-risk

et al. 1243

PM-RMSs that were completely excised and only 22% were low-risk PM-RMSs

Crist et al. 1232

1995 3

Prospective cohort

PFS

5-year PFS of 69% in cohort of PM-RMS patients

(Continues)